DVP, WW Clinical Research Clinical Challenges to Device Innovation: Bioabsorbable DES – Industry View Stanley E. Fink, PhD DVP, WW Clinical Research Abbott Vascular

Stanley E. Fink, PhD Employee Abbott Vascular

Bioresorbable Vascular Scaffolds Delivery System – compatible with current tools and procedures Bio(re/ab)sorbable Scaffold – gradual degradation with well understood metabolization Drug - Known drug, with dose density and controlled release similar to approved DES

Clinical Program Challenges Traditionally gather early safety data (FIM) FIM: patients 30 – 130 - differs in requirement to understand mechanisms of action: via diverse imaging modalities Angio, IVUS, Virtual Histology, Palpography, OCT, MSCT Multiple time points Critically Important

Clinical Program Challenge Larger Experience: single arm trial; 200 – 1000 patients More sizes Overlapping More complex lesions Some continued imaging Clinical Endpoints Various time points Bridging absorption timepoint Supporting long-term safety data for IDE & PMA

Clinical Challenges Short Term IDE – Prospective, randomized, single masked, multicenter trial Clinical Endpoint TLF ~ 1500-2000 patients Control Arm: state-of-the-art metallic DES Clinical follow-up: 30 days, 6 months, 1-5 years One year: must perform as DES Some imaging IVUS, OCT? – dependent on OUS data Deliverability Acute and sustained revascularization Vessel Scaffolding Drug pK

Clinical Challenges Long Term Demonstrating Benefits Reduction in DAPT Reduction in lesion/scaffold thrombosis Complete revascularization – multiple vessel – full polymer jacket Vulnerable / non flow limiting lesions Reduction in lesion specific angina Flat TLF slope over time Vascular remodeling Restoration of vasomotor function CABG options maintained Health Economics